BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/ETN RADIOLUC SHORT

    MDR report key: 3200843 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04203
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ANOMALIES WERE FOUND. PRODUCT DEVELOPMENT EVALUATION NOT YET COMPLETE. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED INSERTION HANDLE SHOWED BREAKAGE OF THE WHOLE COMPOSITION OF THE INSERTION HANDLE. THE INSTRUMENT IS IN A DESOLATE STATE. FURTHERMORE THE CENTERING AND GUIDING GROOVES ARE DAMAGED. THIS IS A DEFINITE INDICATION OF EXCEEDINGLY HIGH FORCES ON THE INSTRUMENT, WHICH WAS LEADING TO THIS DAMAGE. FURTHER INVESTIGATIONS OF OUR MATERIAL AND MANUFACTURING DOCUMENTS SHOW NO DEVIATION ACCORDING TO OUR SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: INSERTION GUIDE BROKE AT THE SHAFT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303206 INSERT-HANDLE F/ETN RADIOLUC SHORT FZX SYNTHES GMBH 3286196

    Patients

    Seq Age Sex Outcome Treatment
    1